Meditec OPL3 Nd:YAG Laser
PMA P830025
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP830025 | Date6 Sep 1985 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade Name
- Mli 1000 Nd:yag Op Laser
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- PMA Number
- FDA Product Code
- LOI
- Device Class
- Class III
- Advisory Committee
- Ophthalmic
- FDA Decision
- APPR Approved
- PMA Supplement
- S002
Overview
AI-generated summary, 18 Sep 2026
The Meditec OPL3 Nd:YAG Laser is an ophthalmic laser device classified as a Neodymium:Yag laser for ophthalmic uses other than posterior capsulotomy and cutting pupillary. It is manufactured by Medical Laser, Inc. and identified by the trade name MLI 1000 ND:YAG OP LASER.
This device received FDA PMA approval (P830025, supplement S002) on September 6, 1985, and is classified as a Class III device. It is supplied as a reusable system requiring appropriate clinical settings and operator training, with no indications of sterility, single-use status, or MRI safety provided in the data.
Other devices from Medical Laser, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the generic name and device class of the Meditec OPL3 Nd:YAG Laser?
The generic name is Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary, and it is classified as a Class III device under FDA regulations.
What authorization does the Meditec OPL3 Nd:YAG Laser have, and when was it approved?
The device has FDA PMA authorization (P830025, supplement S002) and was approved on September 6, 1985, following a decision date of 1985-09-06.
Who manufactures the Meditec OPL3 Nd:YAG Laser and what is its trade name?
The device is manufactured by Medical Laser, Inc., and its trade name is MLI 1000 ND:YAG OP LASER, as specified in the device data.